Effect of GLP-1 Receptor Agonist, Exenatide on Glucosuria Induced Elevation in ENDOGENOUS GLUCOSE PRODUCTION (EGP)
In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous glucose production) and plasma glucose concentration in diabetic subjects. Researchers will examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration.
- Diabetes Mellitus, Type 2
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- Accepts Healthy Volunteers
- BMI = 25-35 kg/m^2
- must be drug naïve and/or on a stable dose (more than 3 months) of metformin and/or sulfonylurea
- HbA1c >7.0% and <10.0%
- Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis.
- Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.
- Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded
- Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Byetta / Bydureon
|Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc||
|4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg||
Byetta/Bydureon plus Dapagliflozin
|Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS Dapagliflozin: 4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg||
|Placebo group (4 weeks and 12 weeks)||
- NCT ID
- The University of Texas Health Science Center at San Antonio
Study ContactEugenio Cersosimo, MD, PhD
This study will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose concentration compared to each agent alone.